JAMP RIVASTIGMINE

1 Dosing Considerations • Dose escalation for patients with serious comorbid diseases should be undertaken with particular caution. 5 mg once a day) and to escalate dosage at a slower rate than for adults (see 7 WARNINGS AND PRECAUTIONS).

• Low Body Weight: Patients with body weight below 50 kg may experience more adverse events and may be more likely to discontinue due to adverse events. Particular caution should be exercised when titrating these patients to the maintenance dose.

5 mg once a day) and that dose escalation be slower than that recommended for adults. Caution should be used when titrating renal or hepatically impaired patients (see 10 CLINICAL PHARMACOLOGY). • In a population of cognitively-impaired individuals, safe use of this and all other medications may require supervision (see 7 WARNINGS AND PRECAUTIONS, Patient and Caregiver Counselling Information).

g. hypertension and hallucinations in patients with Alzheimer’s dementia, and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson’s disease) have been observed shortly after dose increase.

They may respond to a dose reduction. In other cases, JAMP Rivastigmine Capsules has been discontinued. 2 Recommended Dose and Dosage Adjustment JAMP Rivastigmine Capsules (rivastigmine capsules) should only be prescribed by (or following consultation with) clinicians who are experienced in the diagnosis and management of dementia.

JAMP Rivastigmine Capsules should be taken with food in divided doses in the morning and evening. Adults The usual maintenance dose range for JAMP Rivastigmine Capsules is 6-12 mg / day. The following dosage escalation recommendations, derived from clinical trial data, are provided as a guide only, as individual tolerance to dose increases will vary.

The incidence of cholinergic adverse events associated with JAMP Rivastigmine Capsules increase with dose and are more prevalent in females (see 8 ADVERSE REACTIONS). d. (3 mg / day). d. (6 mg / day). Dose increases above 6 mg / day should proceed cautiously.

d. d. (12 mg / day) should also be based on good tolerability of the current dose and should only be considered after a minimum of two weeks treatment at that dose level. d. (12 mg / day). ; based on tolerability, with a minimum of 4 weeks at each dose.

). d. (3 mg / day). d. (6 mg / day). Dose increases above 6 mg / day should proceed cautiously. d. d. (12 mg / day) should also be based on good tolerability of the current dose and should only be considered after a minimum of two weeks treatment at that dose level.

d. (12 mg / day). ; based on tolerability, with a minimum of 4 weeks at each dose. 5 Missed Dose The missed dose should be taken at the next scheduled dose. Doses should not be doubled. Following initiation of therapy or any dosage increase, patients should be closely monitored for adverse effects.

g. nausea, vomiting, abdominal pain, loss of appetite) are observed during treatment, the patient should be instructed to stop treatment for several doses and then restart at the same dose level, or lower, as clinically indicated. e.

d. , as clinically indicated) and be re- titrated to their maintenance dose as described above (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). If side effects persist, the drug should be discontinued. 5 OVERDOSAGE Symptoms: Manifestations include nausea, vomiting, diarrhea, abdominal pain, dizziness, tremor, headache, somnolence, bradycardia, confusional state, hyperhidrosis, hypertension, hallucinations and malaise.

Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterised by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.

Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate. In a documented case of extreme overdose with transdermal rivastigmine additional symptoms have been observed including fall, elevated creatinine level, signs of urinary infection and acute renal failure with anuria.

, Skin). • Patients with history of QT prolongation and / or torsade de pointes, including congenital long QT syndromes, history of cardiac arrhythmias (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). 1 Dosing Considerations • Dose escalation for patients with serious comorbid diseases should be undertaken with particular caution.

5 mg once a day) and to escalate dosage at a slower rate than for adults (see 7 WARNINGS AND PRECAUTIONS). • Low Body Weight: Patients with body weight below 50 kg may experience more adverse events and may be more likely to discontinue due to adverse events.

Particular caution should be exercised when titrating these patients to the maintenance dose. 5 mg once a day) and that dose escalation be slower than that recommended for adults. Caution should be used when titrating renal or hepatically impaired patients (see 10 CLINICAL PHARMACOLOGY).

• In a population of cognitively-impaired individuals, safe use of this and all other medications may require supervision (see 7 WARNINGS AND PRECAUTIONS, Patient and Caregiver Counselling Information). g. hypertension and hallucinations in patients with Alzheimer’s dementia, and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson’s disease) have been observed shortly after dose increase.

They may respond to a dose reduction. In other cases, JAMP Rivastigmine Capsules has been discontinued. 2 Recommended Dose and Dosage Adjustment JAMP Rivastigmine Capsules (rivastigmine capsules) should only be prescribed by (or following consultation with) clinicians who are experienced in the diagnosis and management of dementia.

JAMP Rivastigmine Capsules should be taken with food in divided doses in the morning and evening. Adults The usual maintenance dose range for JAMP Rivastigmine Capsules is 6-12 mg / day. The following dosage escalation recommendations, derived from clinical trial data, are provided as a guide only, as individual tolerance to dose increases will vary.

• Patients with known hypersensitivity to rivastigmine, to other carbamate derivatives or to the excipients of the formulation. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with severe liver impairment since rivastigmine has not been studied in this population.

, allergic dermatitis (disseminated), Stevens-Johnson syndrome) with rivastigmine, oral or transdermal patch (see 7 WARNINGS AND PRECAUTIONS, Skin). • Patients with history of QT prolongation and / or torsade de pointes, including congenital long QT syndromes, history of cardiac arrhythmias (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).